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OncoMatch/Clinical Trials/NCT06990880

A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer

Is NCT06990880 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies GSK5458514 for neoplasms, prostate.

Phase 1/2RecruitingGlaxoSmithKlineNCT06990880Data as of May 2026

Treatment: GSK5458514The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer. The study will be conducted in two parts - Part 1 (dose escalation phase) and Part 2 (dose expansion phase).

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Extracted eligibility criteria

Biomarker criteria

Required: FOLH1 expression

retrospective detection of Prostate-specific membrane antigen (PSMA) expression and other biomarker analysis

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: antiandrogen — novel anti-androgen receptor therapy

Has prior novel anti-androgen receptor therapy failure

Must have received: taxane

had treatment failure with 1-2 taxane-based chemotherapy regimens including for metastatic hormone sensitive prostate cancer

Cannot have received: PSMA radionuclide therapy

Exception: unless participant received <2 cycles

Prior PSMA radionuclide therapy within 2 months prior to GSK5458514 unless participant received <2 cycles

Cannot have received: PSMA CAR-T cell therapy

Prior PSMA-Chimeric antigen receptor T cell therapy (CAR-T) cell therapy

Cannot have received: PSMA T cell engager

PSMA (T cell engager) TCE/ Bispecific T cell engagers (BiTE) or other prostate Tumor-associated antigens (TAA) specific T cell engager (TCE)

Cannot have received: bone marrow transplant

any history of prior allogenic or autologous bone marrow transplant

Cannot have received: solid organ transplant

other solid organ transplant

Cannot have received: systemic biologic therapy

Any anti-cancer therapy or prior systemic biologic therapy, including immunotherapy within 4 weeks of start dose

Lab requirements

Liver function

ALT ≤2.5x ULN or ≤5x ULN if documented history of liver metastases; total bilirubin ≤1.5x ULN; no cirrhosis or current unstable liver or biliary disease

Has an Alanine aminotransferase (ALT) value >2.5x upper limit of normal (ULN) or >5x ULN if documented history of liver metastases. Has a total bilirubin value >1.5x ULN. Has cirrhosis or current unstable liver or biliary disease per investigator assessment

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • GSK Investigational Site · Denver, Colorado
  • GSK Investigational Site · Nashville, Tennessee

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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